CME America recalls BodyGuard Microset (REF: A12:161XPS) due to potential infusion delivery inaccuracies that could cause over or under therapy. Affected units include all lots within expiry date.
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
CME America is recalling BodyGuard Microset infusion sets because they may deliver therapy at up to 17.5% over or 42.8% under the intended dose. This risk of incorrect dosing could lead to serious health consequences for users.
The infusion sets may have delivery inaccuracies of up to 17.5% over or 42.8% under the intended dose. This can cause over-infusion or under-infusion of therapy, potentially leading to serious health issues.
Patients using the BodyGuard Microset infusion system for therapy are affected. Those with medical conditions requiring precise dosing are at higher risk.
Check for the BodyGuard Microset with reference number A120-161XPS. All lots within the expiry date are affected.
Identify the reference number A120-161XPS on the infusion set packaging.
The BodyGuard Microset may have delivery inaccuracies of up to 17.5% over or 42.8% under the intended dose, which could cause over- or under-infusion of therapy.
Check the reference number on the packaging. If it matches A120-161XPS, contact CME America for guidance.
The recall record does not specify a remedy or fix.
We’ve drafted a message you can send CME America to request your refund or repair — edit it as you like.
Subject: Recall Z-2557-2020 — CME America CME America Hello, I own a CME America that is covered by recall Z-2557-2020 from CME America. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
